Comparing different radiation therapies for nasopharyngeal carcinoma
Official title: Phase 3 Trial Comparing IMRT or IMPT Plus CIRT for Patients With NPC
Run by Shanghai Proton and Heavy Ion Center · NCT06846450 · Data updated 2026-11-12
This study is testing whether a new combination of proton and carbon ion radiation therapy is just as effective and safe as a different combination of photon and carbon ion radiation therapy for people newly diagnosed with nasopharyngeal carcinoma.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 470 (estimated) |
| Sponsor | Shanghai Proton and Heavy Ion Center Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | January 31, 2031 |
| Study ends | January 31, 2031 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT06846450 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 70 with pathologically confirmed nasopharyngeal carcinoma and no distant metastasis.
✕Probably not a fit
Patients with distant metastasis or those who have had previous radiotherapy to the head and neck region will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 3 non-inferiority trial aims to compare the efficacy and toxicity of proton radiation therapy combined with carbon ion radiation therapy against photon radiation therapy combined with carbon ion radiation therapy for patients with newly diagnosed nasopharyngeal carcinoma. Participants will be randomly assigned to receive either treatment approach, and the study will evaluate progression-free survival as the primary outcome, along with secondary outcomes including overall survival and patient-reported outcomes. The trial utilizes a web-based randomization system to ensure balanced allocation based on disease stage and response to prior chemotherapy.
Why it matters
Potential benefit: If successful, this study could provide a more effective and less toxic treatment option for patients with nasopharyngeal carcinoma.
How similar studies have gone: Other studies have shown promising results with proton and carbon ion therapies, but this specific comparison is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Willingness to sign the written informed consent. * Pathologically confirmed Nasopharyngeal carcinoma. * Patients with any stage of disease except distant metastasis. * Age: ≥ 18 and ≤ 70 years old. * Eastern Cooperative Oncology Group score: 0-1. * Adequate laboratory test results. * Willingness to accept adequate contraception. Exclusion criteria: * Presence of distant metastasis. * Previous radiotherapy to head and neck region. * Previous surgery (except for biopsy) for the primary lesion or cervical lymph nodes. * History of malignant tumor within the past 5 years. * Presence of multiple primary tumors. * Presence of diseases that may interfere with the evaluation of study endpoints. * Presence of severe major organ dysfunction. * Mental illness that may affect the understanding of informed consent.
Where it's running
-
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Lin Kong
- Email: konglinjiang@163.com
- Phone: 86-38296666
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Nanocrystalline Megestrol Acetate to Help Appetite During Chemoradiotherapy in Nasopharyngeal Carcinoma
This phase 3 trial tests whether taking nanocrystalline megestrol acetate can help people with nasopharyngeal carcinoma who are receiving chemoradiotherapy to keep their appetite and weight better than placebo.
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Becotatug Vedotin plus Anti-PD-1 as maintenance for recurrent/metastatic NPC
This phase 3 trial tests whether adding becotatug vedotin to an anti-PD-1 therapy as maintenance can help people with recurrent or metastatic nasopharyngeal cancer who have stable disease after initial treatment.
-
Intratumoral EDS01 plus toripalimab for recurrent or metastatic head and neck cancer
This phase 1 study tests whether directly injecting a gene‑therapy endostatin product (EDS01) into a tumor, together with the PD-1 inhibitor toripalimab, is safe and shows early signs of activity in adults with recurrent or metastatic head and neck cancer after platinum therapy.
-
Maintenance immunotherapy with deferred salvage radiotherapy after response to chemoimmunotherapy in recurrent nasopharyngeal cancer
This study tests whether continuing immunotherapy and delaying salvage radiotherapy after an initial chemoimmunotherapy response can help people with unresectable recurrent nasopharyngeal cancer live longer and feel better.
-
Becotatug vedotin added to radiation and adjuvant therapy for locally advanced nasopharyngeal cancer with a poor response to induction chemo‑immunotherapy
This will test whether adding becotatug vedotin during radiation and afterward helps people with locally advanced nasopharyngeal cancer who had a suboptimal response to induction chemotherapy combined with immunotherapy.
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IMRT-only treatment for stage IB nasopharyngeal cancer without high-risk features
This trial will test whether IMRT alone can control stage IB nasopharyngeal cancer without high-risk features in adults aged 18–70.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.